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The effect of cognitive behavioral therapy on anxiety, stress, and depression in high-risk, HPV-positive women

Protocol summary

Study aim
Determining the effect of cognitive behavioral therapy on anxiety, stress and depression of high-risk HPV positive women
Design
A clinical trial with a control group, with parallel groups, a blind strain, randomized, on 66 patients. Blocking method is used for randomization.
Settings and conduct
The place of sampling is the women's clinic of Imam Khomeini Hospital in Ahvaz in the form of 8 cognitive behavioral therapy sessions.
Participants/Inclusion and exclusion criteria
Conditions for entering the study: 1. According to the Dass 21 questionnaire, have mild to moderate anxiety, stress and depression. 2. Living in Ahvaz city 3. Ability to participate in training sessions 4. Proficiency in Persian language 5. Having a positive HPV test result of high-risk types 6. Having a smart mobile phone Conditions for withdrawing from the study: 1. Unwillingness to continue cooperation 2. The occurrence of any unfortunate events such as the death of loved ones 3. Taking psychiatric drugs 4. Addiction to alcohol and drugs 5. Simultaneous use of sedation methods 6. Absence more than twice in counseling sessions
Intervention groups
The test group will undergo cognitive-behavioral counseling in 8 sessions of 45 minutes once a week. The control group will not receive any counseling during the study.
Main outcome variables
The purpose of this study is to investigate the effect of cognitive behavioral therapy on anxiety, stress and depression of high-risk HPV positive women. If this study achieves the desired result, high-risk HPV positive women can reduce their anxiety, stress and depression by receiving cognitive behavioral counseling, and as a result, follow up the treatment and recovery process faster and the likelihood of cervical cancer is reduced. to be

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240518061834N1
Registration date: 2024-05-31, 1403/03/11
Registration timing: prospective

Last update: 2024-05-31, 1403/03/11
Update count: 0
Registration date
2024-05-31, 1403/03/11
Registrant information
Name
Delaram Haddadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5246 7198
Email address
hadadi.d@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-08, 1403/03/19
Expected recruitment end date
2024-11-19, 1403/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive behavioral therapy on anxiety, stress, and depression in high-risk, HPV-positive women
Public title
The effect of cognitive behavioral therapy on anxiety, stress, and depression in high-risk, HPV-positive women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
According to the Dass 21 questionnaire, have mild to moderate anxiety, stress and depression Living in Ahvaz city Ability to participate in training sessions Proficiency in Persian language Having a positive HPV test result is one of the high-risk types Having a smart phone
Exclusion criteria:
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Care provider
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
First, we prepare the general list of HPV positive people, we evaluate the stress and anxiety for all people, then according to the entry and exit criteria, we select the eligible people through a list, and finally, 66 people are randomly divided into two groups. control and intervention are allocated (33 people in each group). To assign people to two groups, after selecting the samples, 11 blocks of 6 are designed and in each block randomly one of the 6 combinations such as AAABBB, BBBAAA, BABABA, ABABAB, ABBAAB, BABAAB, etc. are placed in the first block in group A, the second and third in group A, the next three in group B, the first in the second block in group B, the second in group A and so on. According to the composition placed in each block, people are placed in groups A and B. After assigning people in groups, we randomly select one group as the control group and one group as the intervention group. Then the test group will undergo cognitive behavioral counseling in 8 sessions of 45 minutes once a week
Blinding (investigator's opinion)
Single blinded
Blinding description
People are divided into two control and intervention groups by random block method
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences
Street address
Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
61355_45
Approval date
2024-05-10, 1403/02/21
Ethics committee reference number
IR.AJUMS.REC.1403.059

Health conditions studied

1

Description of health condition studied
High risk HPV positive women
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anxiety, stress and depression
Timepoint
At the beginning of the study, at the end of 8 counseling sessions, one month after the end of the intervention
Method of measurement
Questionnaire dass 21

Secondary outcomes

1

Description
Anxiety, stress, depression
Timepoint
The beginning of the study, in the last session of cognitive behavioral therapy, one month after the end of the intervention
Method of measurement
dass questionnaire 21

Intervention groups

1

Description
Intervention group: This group receives 8 45-minute sessions of cognitive behavioral therapy once a week
Category
Treatment - Other

2

Description
Control group: The control group does not receive any counseling during the study.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Ahvaz
Full name of responsible person
Mohammad Amin Zargar
Street address
Ahvaz, Azadegan St., Imam Khomeini Medical Education Center, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 1222 2114
Email
himam@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakirkish
Street address
Golestan St
City
ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8395
Email
eduaum@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Abbaspour
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8395
Email
Abbaspoorzahra7@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Abbaspour
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8395
Email
Abbaspoorzahra7@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Delaram Haddadi
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
South Basij St
City
Mobarake
Province
Isfehan
Postal code
8481778881
Phone
+98 31 5246 7198
Email
delaramhdd1994@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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